CompletedPhase 1

Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.

Tanzania60 participantsStarted 2023-08-14

Plain-language summary

This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure of a single oral dose of piperaquine (PQP) in a dispersible granule formulation compared to the PQP hard tablet formulation in the fasted state (Part 1), to advise the selection of dose when the PQP granule formulation is administered in a fed state in healthy adult participants. Part 2 will assess the effect on different types of meal composition on the PK of a single dose of PQP granule formulation in healthy adult participants.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female or Male aged ≥18 years to ≤55 years at the date of signing informed consent.
. Ability to provide written, personally signed, and dated informed consent to participate in the trial, in accordance with the ICH Good Clinical Practice (GCP) and applicable regulations, before any trial-related procedures.
. An understanding, ability, and willingness to fully comply with trial procedures and restrictions.
. Female participants must agree to follow contraceptive requirements as indicated in Section 13.2.2, from at least 30 days prior to first dosage to 16 weeks after last dosage.
. Agrees not to donate sperm or ova from the time of the first administration of trial medication until twelve weeks after the end of the systemic exposure of the trial drug.
. Participants must have a body weight of 50 kg or greater and a BMI between 18.0 kg/m² - 30.0 kg/m² (inclusive) at screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relative Bioavailability (Frel) of the Maximum Observed Plasma Concentration (Cmax) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel Cmax).

Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.

Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 72h Hours (AUC0-72h) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-72h).

Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.

Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-t).

Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.

Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 168 Hours (AUC0-168h) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-168h.

Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.

Trial details

NCT IDNCT05930782

SponsorMedicines for Malaria Venture

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-06

Results submitted2024-08-14

View on ClinicalTrials.gov More Malaria trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female or Male aged ≥18 years to ≤55 years at the date of signing informed consent.
. Ability to provide written, personally signed, and dated informed consent to participate in the trial, in accordance with the ICH Good Clinical Practice (GCP) and applicable regulations, before any trial-related procedures.
. An understanding, ability, and willingness to fully comply with trial procedures and restrictions.
. Female participants must agree to follow contraceptive requirements as indicated in Section 13.2.2, from at least 30 days prior to first dosage to 16 weeks after last dosage.
. Agrees not to donate sperm or ova from the time of the first administration of trial medication until twelve weeks after the end of the systemic exposure of the trial drug.
. Participants must have a body weight of 50 kg or greater and a BMI between 18.0 kg/m² - 30.0 kg/m² (inclusive) at screening.

What they're measuring

Relative Bioavailability (Frel) of the Maximum Observed Plasma Concentration (Cmax) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel Cmax).

Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.

Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria